MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2015-12-29 for COBAS 6000 C501 MODULE 04745914001 manufactured by Roche Diagnostics.
[34597316]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[34597317]
The customer received a questionable c-reactive protein (crp) result for one patient sample. The initial result was 1. 138 mg/dl and was reported to doctor who hospitalized the patient. At the hospital, the patient was retested for crp and the result did not agree with the initial result. No specific data could be provided. On (b)(6) 2015, the doctor asked customer to repeat the test. The sample from (b)(6) 2015 was tested with a result of 0. 354 mg/dl. Of the data provided, the ion selective electrode (ise) potassium results for the sample were also discrepant. The initial result on (b)(6) 2015 was 4. 62 and the repeat result on (b)(6) 2015 was 5. 21. The unit of measure was not provided. The patient was not adversely affected. The crp reagent lot number was 616063. The expiration date was requested, but was not provided. The potassium electrode lot number and expiration date were requested, but were not provided. As multiple assays gave differing results upon repeat testing, a general instrument issue was suspected. It was noted the customer was not using the recommended sample tube rack adapters which might have allowed the sample tube to lean and led to a pipetting issue.
Patient Sequence No: 1, Text Type: D, B5
[37070977]
A specific root cause could not be identified, but a preanalytic issue was suspected. A general reagent issue was not likely. The field service representative cleaned the rinse arm nozzles and probes, checked the volumes being pipetted, the tubes, valves, photometer, and mixer. All were acceptable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-06142 |
| MDR Report Key | 5332519 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-12-29 |
| Date of Report | 2016-01-27 |
| Date of Event | 2015-12-09 |
| Date Mfgr Received | 2015-12-17 |
| Date Added to Maude | 2015-12-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DCN |
| Date Received | 2015-12-29 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-12-29 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-29 |